Group-Mediated Cognitive Behavioral Resistance Exercise Intervention in Head and Neck Cancer Patients Undergoing Chemoradiation Treatment

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    20
  • sponsor
    Ohio State University Comprehensive Cancer Center
Updated on 22 March 2022

Summary

This clinical trial examines a group-mediated cognitive behavioral resistance exercise intervention in head and neck cancer patients who are undergoing chemoradiation treatment. Chemoradiation is the established standard of care for locally advanced head and neck cancer patients. However, many head and neck cancer patients experience clinically meaningful declines in muscle mass, physical function, and quality of life during and following treatment. Resistance exercise has been shown to improve muscle mass, body composition, and physical function when integrated with appropriate standard of care nutritional counseling/supplementation. This trial may help researchers determine the important of integrating exercise interventions with routine cancer care.

Description

PRIMARY OBJECTIVES:

I. To determine the feasibility of implementing a group-mediated cognitive behavioral (GMCB) personalized resistance exercise (RE) intervention in head and neck cancer (HNCa) patients undergoing chemoradiation (CRT).

II. To examine the effects of GMCB RE intervention upon functional limitations, body composition, and quality of life (QOL) in HNCa patients undergoing CRT.

OUTLINE

Patients undergo personalized resistance exercises over 1 hour daily. Patients receive dietary counseling over 60 minutes at week 1 and then over 15-30 minutes weekly for up to 6 weeks. Patients also receive group-based behavioral counseling twice weekly (BIW) in weeks 1-8, once a week (QW) in weeks 9-12, and then twice a month in weeks 13-24.

Details
Condition Locally Advanced Head and Neck Squamous Cell Carcinoma
Treatment questionnaire administration, quality-of-life assessment, Resistance Training, Counseling, Dietary Counseling and Surveillance
Clinical Study IdentifierNCT04733495
SponsorOhio State University Comprehensive Cancer Center
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with locally advanced human papillomavirus (HPV)+ stage III-IV head and neck (HN) squamous cell carcinomas undergoing concurrent chemotherapy and radiation therapy. Patients with prior cancers or post-surgical patients needing adjuvant therapy will not be allowed to participate in this study
Undergoing planned course of standard of care CRT for a total of 33 to 35 RT fractions (six and a half or seven weeks of treatment)
Adults 18 years old (yo) or older who have clearance from their primary care provider (PCP) or medical oncologist to participate in resistance exercises during treatment. These patients will be monitored very closely on a weekly basis during the trial
All participants must be free of severe heart or systemic disease or medical contraindications that would make supervised RE participation unsafe
Receive medical clearance to participate from treating primary care physician or Medical Oncologists
Ability to understand and the willingness to sign a written informed consent
Willing and physically able to participate in RE

Exclusion Criteria

Severe heart or systemic disease or medical contraindications to exercise
Diagnosis of cancer other than HNCa
Musculoskeletal/Neurological disorder inhibiting them from safe exercise
Pregnant or nursing women
Unable to give informed consent
Clear my responses

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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